Characterizing Pregnant Women With and Without Evidence of Heart Failure and Non-Pregnant Women With Heart Failure: A Propensity Score Matched Analysis

    Basic Details
    Date Posted
    Tuesday, June 21, 2022
    Status
    Complete
    Description

    This analysis examines the clinical characteristics in three cohorts including pregnant women with and without heart failure (HF) and non-pregnant women with HF, characterizes use of oral HF-related therapies before, during, and after pregnancy, and examines maternal and fetal outcomes among pregnant patients with and without HF in the Sentinel Distributed Database (SDD). This report follows a previous study, Pregnancy among Women with Heart Failure: A Descriptive Analysis.

    The study period included data from January 1, 2010 to March 31, 2021. We distributed this request to four Sentinel Data Partners on December 3, 2021.

    The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 - March 31, 2021
    Study Type
    Modular Program
    Assessment Type
    Safety Analyses
    Population / Cohort
    Females 15 to 54 years of age
    Data Sources
    Sentinel Distributed Database (SDD)